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BioWorld - Tuesday, April 28, 2026
Home » Topics » Regulatory, Medical technology

Regulatory, Medical technology
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Researcher looking through a microscope

NIH changes set industry up for workforce, ideas drought

March 7, 2025
By Anette Breindl
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
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NHS building

New AI fall prediction tool being rolled out across the NHS

March 7, 2025
By Shani Alexander
The U.K.’s national health service (NHS) is rolling out a new artificial intelligence (AI)-powered tool which can predict a patient’s risk of falling with a 97% accuracy rate. The AI software designed by Cera Care Ltd. is already in use in more than two-thirds of NHS integrated care systems across the country and NHS England hopes that the tool will prevent around 2,000 falls and hospital admissions each day.
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Map of Europe, Medical Device Regulation (MDR) text

EU MDR backlog could create an opportunity for Australia

March 7, 2025
By Tamra Sami
A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.
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Martin Makary, nominee for U.S. FDA commissioner

US FDA nominee HELPed on the way to confirmation

March 6, 2025
By Mari Serebrov
Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.
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Jay Bhattacharya, nominee for U.S. NIH director

Bhattacharya shares his vision for US NIH

March 5, 2025
By Mari Serebrov
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
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3D illustration of knee joint

PTAB affirms rejection of 2014 patent application for cartilage

March 5, 2025
By Mark McCarty
The widespread need for cartilage repair may have bred optimism on the part of Spinalcyte LLC when it filed a related patent in 2014, but the Patent Trial and Appeal Board has affirmed a rejection of the patent due to lack of enablement, an object lesson regarding the need for clarity in patent applications.
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FDA icons and doctor

FDA draft for OI contrast agents allows intrasubject comparators

March 5, 2025
By Mark McCarty
The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.
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Trump’s EOs keep coming as US agencies await new leadership

March 4, 2025
By Mari Serebrov
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.
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canada-court-regulatory.png

Health Canada jumps into PCCP filings for machine learning

March 4, 2025
By Mark McCarty
The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.
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Product recall concept image

Philips pulls Tack device due to problems with deployment

March 4, 2025
By Mark McCarty
Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.
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